BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Innofiber

    Reg #: 3003683459 · FEI: 3003683459 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Innofiber
    Registration Number
    3003683459
    FEI Number
    3003683459
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 SPRATT TECHNOLOGY WAY
    City
    STERLING
    State
    MA
    ZIP
    01564
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162416

    Owner / Operator

    Firm Name
    Innofiber
    Operator Number
    9090323
    Address
    2 SPRATT TECHNOLOGY WAY, --
    City
    Sterling
    State
    MA
    Postal Code
    01564
    Country
    US
    Correspondent
    Lorri - Wallace

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)